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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ESTEEM+ - 00768455112036

Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Opaque, 1 3/8" (35Mm)
CONVATEC, PURCHASING DEPARTMENT
416733
In Commercial Distribution

  • 10768455112033 ()
  • 00768455112036 ()
  • 00768455188437 ()


  • One-piece intestinal ostomy bag, open-ended

ESTEEM+ - 00768455112029

Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Tranparent, 1 3/8" (35Mm)
CONVATEC, PURCHASING DEPARTMENT
416732
In Commercial Distribution

  • 10768455112026 ()
  • 00768455112029 ()
  • 00768455188420 ()


  • One-piece intestinal ostomy bag, open-ended

ESTEEM+ - 00768455111992

Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Opaque, 1 3/16" (30Mm)
CONVATEC, PURCHASING DEPARTMENT
416729
In Commercial Distribution

  • 10768455111999 ()
  • 00768455111992 ()
  • 00768455188413 ()


  • One-piece intestinal ostomy bag, open-ended

ESTEEM+ - 00768455111985

Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Tranparent, 1 3/16" (30Mm)
CONVATEC, PURCHASING DEPARTMENT
416728
In Commercial Distribution

  • 10768455111982 ()
  • 00768455111985 ()
  • 00768455188406 ()


  • One-piece intestinal ostomy bag, open-ended

ACTIVELIFE - 00768455106028

ActiveLife One-Piece Cut-to-Fit Closed-End Pouch with Skin Barrier and Filter, with 1 Sided Comfort Panel, Opaque, 3/4 in. (19 mm)
CONVATEC, PURCHASING DEPARTMENT
413141
Not in Commercial Distribution

  • 10768455106025 ()
  • 00768455106028 ()
  • 80768455106024 ()


  • One-piece intestinal ostomy bag, closed-ended

ACTIVELIFE - 00768455102433

ActiveLife One-Piece Cut-To-Fit Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Opaque, 3/4 in (19 mm)
CONVATEC, PURCHASING DEPARTMENT
175768
Not in Commercial Distribution

  • 10768455102430 ()
  • 00768455102433 ()
  • 80768455102439 ()


  • One-piece intestinal ostomy bag, closed-ended

ACTIVELIFE - 00768455102372

ActiveLife One-Piece Cut-To-Fit Closed-End Pouch with Skin Barrier and Filter, with One Sided Comfort Panel, Transparent, 3/4 in (19 mm)
CONVATEC, PURCHASING DEPARTMENT
175761
Not in Commercial Distribution

  • 10768455102379 ()
  • 00768455102372 ()
  • 80768455102378 ()


  • One-piece intestinal ostomy bag, closed-ended

ACTIVELIFE - 00768455102044

Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 2" (50Mm.)
CONVATEC, PURCHASING DEPARTMENT
125343
In Commercial Distribution

  • 10768455102041 ()
  • 00768455102044 ()
  • 00768455180578 ()


  • One-piece intestinal ostomy bag, open-ended

ACTIVELIFE - 00768455102006

Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 12" Opaque, 1" (25Mm.)
CONVATEC, PURCHASING DEPARTMENT
125339
In Commercial Distribution

  • 10768455102003 ()
  • 00768455102006 ()
  • 00768455180530 ()


  • One-piece intestinal ostomy bag, open-ended

ACTIVELIFE - 00768455101979

Activelife® One-Piece Drainable Pre-Cut Pouch With Stomahesive® Skin Barrier, W/1-Sided Comfort Panel W/Tape 10" Opaque, 2" (50Mm.)
CONVATEC, PURCHASING DEPARTMENT
125336
In Commercial Distribution

  • 10768455101976 ()
  • 00768455101979 ()
  • 00768455180509 ()


  • One-piece intestinal ostomy bag, open-ended

SpineUs System - G618000010

The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
VERDURE IMAGING, INC.
000010
In Commercial Distribution

  • G618000010 ()


  • Ultrasound imaging system operation software
  • Hand-held ultrasound imaging system, body-surface
  • Ultrasound imaging system operator console

Nonagon - 07290018446102

The Nonagon N9 device is a home use device. The device is comprised of a handheld unit that connects with a smartphone and a dedicated smartphone software application that runs on the user's personal smartphone An API is defined to enable healthcare providers to communicate with the device. The Device enables user’s examination at home with or without the guidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit's functionality and processes and displays the collected data. The N9 device measure, record, and transmit data of auscultation sound of human body (lung, hear, abdomen), temperature, oxygen saturation (SpO2) and pulse rate, and can be used to send images of an examined body part. In addition, the device includes otoscope where images of the ear can be transmitted to the healthcare provider.
NONAGON LTD
N9
In Commercial Distribution

  • 07290018446102 ()
  • 17290018446109 ()
MHD-100-02-001

  • Pulse oximeter
  • Electronic acoustic stethoscope
  • Otoscope, direct
  • Infrared patient thermometer, skin

TytoHome - 07290016672763

TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672770 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672794 Tyto Stethoscope and 7290016672800 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672760 when packed in 6 pack and with 27290016672767 when packed in 48 pack.
TYTO CARE LTD
TytoHome G2 US
In Commercial Distribution

  • 07290016672763 ()
900-00015-064

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope

TytoPro - 07290016672756

TytoPro used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672787 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672817 Tyto Stethoscope and 07290016672824 Tyto Otoscope. TytoPro kits are shipped to the US in a logistic carton labeled with DI 17290016672753 when packed in 6 pack and with 27290016672750 when packed in 48 pack.
TYTO CARE LTD
TytoPro G2
In Commercial Distribution

  • 07290016672756 ()
900-00002-062

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope

TytoHome - 07290016672688

TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672473 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672685 when packed in 6 pack and with 27290016672682 when packed in 48 pack .
TYTO CARE LTD
TytoHome G2 US
In Commercial Distribution

  • 17290016672685 ()
  • 07290016672688 ()
  • 27290016672682 ()
900-00015-063

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope

TytoPro - 07290016672541

Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. The TytoPro includes the Tyto Otoscope, Tyto Stethoscope, Tyto Exam Camera, Tyto Thermometer and disposable ear caps and tongue depressor blades. This is a convenience kit containing the following DIs: 07290016672534 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope. TytoPro kits are shipped to the US in a 6 pack logistic carton labeled with DI 17290016672548 and 48 pack logistic carton labeled with 27290016672545.
TYTO CARE LTD
TytoPro G2 US
In Commercial Distribution

  • 07290016672541 ()
  • 17290016672548 ()
  • 27290016672545 ()
900-00002-007

  • Electronic acoustic stethoscope
  • Infrared patient thermometer, skin
  • Otoscope, direct
  • Multi-purpose digital medical camera

TytoHome - 07290016672480

TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 07290016672473 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672487 when packed in 6 pack and with 27290016672484 when packed in 48 pack .
TYTO CARE LTD
TytoHome G2 US
In Commercial Distribution

  • 17290016672487 ()
  • 07290016672480 ()
  • 27290016672484 ()
900-00015-004

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope

TytoHome - 07290016672428

TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, non-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672336 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672404 Tyto Stethoscope and 07290016672411 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672425 when packed in 6 pack and with 27290016672422 when packed in 48 pack .
TYTO CARE LTD
TytoHome US
In Commercial Distribution

  • 17290016672425 ()
  • 07290016672428 ()
  • 27290016672422 ()
900-00015-009

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope

TytoHome - 07290016672305

TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, non-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672336 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672302.
TYTO CARE LTD
TytoHome US
In Commercial Distribution

  • 17290016672302 ()
  • 07290016672305 ()
900-00015-006

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope

TytoPro - 07290016672299

Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672367 Tyto Device (with Tyto Thermometer and Tyto Exam Camera), 07290016672343 Tyto Stethoscope and 07290016672350 Tyto Otoscope. TytoPro kits are shipped to the US in a 6 pack logistic carton labeled with DI 17290016672296 and 54 pack logistic carton labeled with 27290016672293.
TYTO CARE LTD
TytoPro US
In Commercial Distribution

  • 07290016672299 ()
  • 17290016672296 ()
  • 27290016672293 ()
900-00002-005

  • Electronic acoustic stethoscope
  • Infrared patient thermometer, skin
  • Otoscope, direct
  • Multi-purpose digital medical camera

TytoHome - 07290016672213

TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672183 Tyto Device with Basal Thermometer and Exam Camera, 07290016672190 Tyto Stethoscope and 07290016672206 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with 17290016672210.
TYTO CARE LTD
TytoHome
In Commercial Distribution

  • 07290016672213 ()
900-00015

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope

TytoHome - 07290016672053

TytoHome used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope. TytoHome kits are shipped to the US in a logistic carton labeled with DI 17290016672050.
TYTO CARE LTD
TytoHome
In Commercial Distribution

  • 07290016672053 ()
  • 17290016672050 ()
900-00015

  • Electronic acoustic stethoscope
  • Infrared patient thermometer, skin
  • Otoscope, direct
  • Multi-purpose digital medical camera

TytoPro - 07290016672039

Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. TytoCare device with high resolution video and still camera, no-touch infrared basal thermometer, stethoscope, otoscope and tongue depressor attachments. this is a convenience kit containing the following DIs: 07290016672008 TytoCare, 07290016672015 Tyto Stethoscope and 07290016672022 Tyto Otoscope. TytoPro kits are shipped to the US in a logistic carton labeled with DI 17290016672036.
TYTO CARE LTD
TytoPro
In Commercial Distribution

  • 07290016672039 ()
  • 17290016672036 ()
900-00002

  • Multi-purpose digital medical camera
  • Otoscope, direct
  • Infrared patient thermometer, skin
  • Electronic acoustic stethoscope

Nonagon N9+ SmartExam - 27290018446151

No Description
NONAGON LTD
N9+
In Commercial Distribution

  • 27290018446151 ()


  • Pulse oximeter
  • Electronic acoustic stethoscope
  • Otoscope, direct
  • Infrared patient thermometer, skin

Nonagon N9+ - 17290018446154

No Description
NONAGON LTD
N9+
In Commercial Distribution

  • 17290018446154 ()


  • Pulse oximeter
  • Electronic acoustic stethoscope
  • Otoscope, direct
  • Infrared patient thermometer, skin

Medical Panel Insert Kit (TMK-MPI), Coyote Brown w/CAT - 00850018892094

Customizable medical panel insert capable of being oriented vertically or horizontally to fit inside a variety of backpacks or messenger-style bags via a unique hinge system.
Altitude Technologies Inc.
01246CB-CAT
In Commercial Distribution

  • 00850018892094 ()
1246CB-CAT

  • First aid kit, non-medicated, single-use

Medical Panel Insert Kit (TMK-MPI), Coyote Brown w/SOFTT-W - 00850018892056

Customizable medical panel insert capable of being oriented vertically or horizontally to fit inside a variety of backpacks or messenger-style bags via a unique hinge system.
Altitude Technologies Inc.
01246CB
In Commercial Distribution

  • 00850018892056 ()
1246CB

  • First aid kit, non-medicated, single-use

Fourteen Panel PreScreen Plus Cup With Adulterants (CLIA Waived) - 00850557007805

Fourteen Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | EDDP | MDMA | MET | MOR | MTD | OXY | PCP | TCA | THC +AD
MERGERS MARKETING, INC.
PSC-DOA-2145AD
In Commercial Distribution

  • 00850557007805 ()
  • 00850557007812 ()
  • 10850557007819 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Thirteen Panel PreScreen Plus Cup With Adulterants (CLIA Waived) - 00850557007744

Thirteen Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | TCA | THC + AD
MERGERS MARKETING, INC.
PSC-DOA-2135AD
In Commercial Distribution

  • 00850557007744 ()
  • 00850557007751 ()
  • 10850557007758 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Twelve Panel PreScreen Plus Cup With Adulterants (CLIA Waived) - 00850557007706

Twelve Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MDMA | MET | MOR | MTD | OXY | PCP | THC + AD
MERGERS MARKETING, INC.
PSC-DOA-6125AD
In Commercial Distribution

  • 00850557007706 ()
  • 00850557007713 ()
  • 10850557007710 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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